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New treatment option for Systemic Sclerosis (SSc)
Official title The Apollo Device in Systemic Sclerosis for the Management of fatiguE, Raynaud Phenomenon and qualiTy of Life
ClinicalTrials.gov ID: NCT06675344
What this study is testing
- What it's testing
- The purpose of this study it to test the efficacy of a wearable device to improve symptom management and maximize qualify of life in systemic Sclerosis (SSc) patients in a randomized trial. Specifically, we will evaluate if the Apollo Neuro device may improve the two specific symptoms highest ranked by patients as affecting qualify of life (fatigue, Raynaud phenomenon) as co-primary outcomes.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Ability to provide written informed consent,
- Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
- Baseline score ≥55 on the FACIT-Fatigue scale,
- Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
You likely can't join if
- History of sympathectomy or stellate ganglion block
- History of Botox injections to the digits within the last 3 months
- Diabetes mellitus
- Major surgery within 8 weeks
- Hospitalization for any reason within four weeks of the study baseline visit
- Active malignancy
See the full eligibility criteria
- Age ≥ 18 years
- Ability to provide written informed consent,
- Diagnosis of SSc, as defined by the 2013 ACR/EULAR classification of SSc64 with a positive ANA
- Baseline score ≥55 on the FACIT-Fatigue scale,
- Presence of Raynaud phenomenon with ASRAP-SF severity of T-score ≥40,
- Steady daily doses and any immunosuppressive medication, vasodilators or other medications used to treat pulmonary hypertension, antidepressants and anxiolytic use for 4 weeks prior to baseline
- Currently owns and operates an iOS or Android smart phone regularly
- Ability to comply with the clinical visits schedule and the study-related procedures.
- History of sympathectomy or stellate ganglion block
- History of Botox injections to the digits within the last 3 months
- Diabetes mellitus
- Major surgery within 8 weeks
- Hospitalization for any reason within four weeks of the study baseline visit
- Active malignancy
- Pregnant or breastfeeding women,
- End-stage renal disease (estimated glomerular filtration rate \< 15 mL/min/1.73m2) or on dialysis,
- Hepatic insufficiency as defined by function worse than Child-Pugh Class B
- Medication exclusions:
- actively prescribed standing doses of beta-blockers,
- actively prescribed standing doses of sedatives, hypnotics, opioids, benzodiazepines or anti-psychotic medications.
The study team makes the final eligibility decision.
Where it's taking place
- New Orleans, Louisiana, United States
- Ann Arbor, Michigan, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Orleans, Louisiana, United States; Ann Arbor, Michigan, United States; Pittsburgh, Pennsylvania, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.